Safety will be demonstrated by evaluating the freedom from study-related (procedure or device) major adverse cardiovascular and neurological events (MACNE) in the Treatment group at 12 months from Randomization. The secondary safety endpoint is a non-inferiority analysis of the relative risk (RR) of All-Cause MACNE between the Treatment group and the Control group.

Effectiveness will be determined by evaluating the reduction in the relative risk (RRR) of Heart Failure MACNE between the Treatment and Control groups from randomization. The secondary effectiveness endpoints are days alive and out of the hospital for HF through 12 months after the randomization and all-cause death at 12 months from the randomization.

Safety will be demonstrated by evaluating the freedom from study-related (procedure or device) major adverse cardiovascular and neurological events (MACNE) relative to objective performance criteria. The secondary safety endpoint will compare all-cause MACNE in the Treatment group and the Control group.

Effectiveness will be determined by evaluating cumulative HF hospitalizations in the Treatment group vs. the Control group until a specified number of events have been observed. The secondary effectiveness endpoints will compares days alive and out of the hospital for HF events all-cause mortality in the Treatment and Control groups.

The purpose of this clinical study is to evaluate the safety and clinical effectiveness of use of a physician-directed, patient self-management system, guided by left atrial pressure measurements, for use in patients with heart failure. The system allows patients to adjust their HF medications daily based on a physician-directed prescription plan and their current HF status, similar to the manner in which diabetes patients manage their insulin therapy. The goal of the LAPTOP-HF study is to demonstrate reductions in episodes of worsening heart failure (HF) and hospitalizations in patients who are managed with the left atrial pressure (LAP) management system (treatment group) versus those who receive only the current standard of care (control group).

Detailed Description

The Sponsor believes that direct measurements from your heart may provide an accurate, reliable and medically acceptable way of better managing your heart failure prior to your noticing symptoms or being hospitalized. This may enable you and your doctor to take preventative measures, by fine tuning your care including more frequently adjusting your medications with a goal of avoiding hospitalization.

HeartPOD system is a standalone for use in patients not requiring ICD or CRT-D therapy or who are already receiving ICD or CRT-D therapy.

Promote LAP system is a combination device for patients who require ICD or CRT-D therapy in addition to LAP monitoring.

Study Arm (s)

Experimental: Treatment

Patients will be receive a Left Atrial Pressure (LAP) Monitoring System in one of the following devices depending on their medical condition:

Stand-alone implantable LAP monitoring device

CRT-D device with an integrated LAP monitoring device

Intervention: Device: HeartPOD™ System or Promote® LAP System

No Intervention: Control

Patients receive a standard of care cardiac rhythm management device and a hand held Patient Advisor Module (PAM) which provides a daily reminder of their medication schedule

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

486

Completion Date

April 2015

Primary Completion Date

April 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Have ischemic or non-ischemic cardiomyopathy with either a history of reduced or preserved ejection fraction and heart failure for at least 6 months.

NYHA Class III documented at screening visit.

Be receiving appropriate medical therapy for heart failure as per ACC/AHA guidelines (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and beta-blocker) for at least 3 months prior to the randomization visit. Subject has been on stable medications maximized to the subject's tolerance of ACE or ARB and beta-blockers as determined by the study investigator for at least 30 days prior to randomization. Stable is defined as no more than a 100% increase or 50% decrease in dose. These criteria may be waved if a subject is intolerant of ACE, ARB or beta-blockers, or these agents are not indicated under the Guidelines. Such intolerance or lack of indications must be documented.

Have a minimum of one (1) prior hospital admission within the last 12 months for acute exacerbation of HF of at least one (1) calendar date change duration requiring intravenous or invasive HF therapy. If CRT device previously implanted, the heart failure hospitalization must be ≥ 30 days after CRT implantation. Alternatively, if patients have not had a heart failure hospitalization within the prior 12 months, they must have an elevated Brain Natriuretic Peptide (BNP) level of at least 400pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at least 1,500pg/ml, according to local measurement at the time of screening (within 30 days of the screening visit/consent)

Provide informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits.

Are able to schedule Therapy Initiation within two weeks. Enrollment/Randomization may be delayed until this criterion is met.

Exclusion Criteria:

Are under the age of 18 years.

Are pregnant.

Have intractable HF with resting symptoms despite maximal medical therapy (persistent NYHA Class IV and ACC/AHA HF Stage D). This includes patients receiving continuous or intermittent outpatient intravenous vasoactive medications (e.g., IV inotropes, IV vasodilators), patients treated with a ventricular assist device (VAD), and patients who have received a cardiac transplant or are listed for cardiac transplantation and likely to be transplanted within 12 months - even if their functional status has improved to NYHA Class III. Patients listed for cardiac transplantation who are not likely to be transplanted within 12 months and who have improved to NYHA Class III without outpatient IV vasoactive medications or a VAD are eligible for the study, if they meet the other inclusion/exclusion criteria.

Have a resting systolic blood pressure < 80 or > 180 mmHg.

Have an acute MI, Acute Coronary Syndrome, Percutaneous Coronary Intervention (PCI), new cardiac rhythm management device (Pacemaker, ICD, and CRT), CRM system revision, lead extraction or cardiac or other major surgery within 40 days.